- The pressure put on global health systems by the COVID-19 pandemic has led the FDA to temporarily approve changes which have given digital health companies a boost by making it easier for consumers and hospitals to use their technologies.
- Last week, the FDA approved Livongo’s glucose monitors to be used in a hospital setting and also updated its guidance to allow hospitals to use at-home glucose monitors to remotely monitor COVID-19 patients’ blood glucose levels.
- The FDA has also loosened requirements around the use of digital tools for mental health, stating that these “may improve mental health and well-being of patients with psychiatric conditions during periods of shelter-in-place, isolation, and quarantine”.
Analysis & Comments
- The FDA has been overhauling a variety of standard practices over the past few weeks in order to address the challenges created by the COVID-19 pandemic.
- A lot of these changes unsurprisingly focus on (remote) monitoring devices. For example, the FDA expanded the use of connected, non-invasive remote vital-sign monitors to enable more out-of-hospital care at the end of March. Additionally, it released a similar policy for remote ophthalmic (eye-related) assessment and monitoring devices.
- Regarding the changes for glucose monitoring systems, it is worth noting that DexCom and Abbott are also supplying their continuous glucose monitoring systems (CGMs) to hospitals at the moment and according to the Wall Street Journal, 86 hospitals have requested DexCom’s CGMs.
- The FDA is not alone in this: the Centers for Medicare and Medicaid (CMS) has temporarily expanded telehealth benefits, while the Federal Communications Commission (FCC) enacted a US$200m telemedicine initiative focussed on expanding the required infrastructure, and the Department of Veterans Affairs has placed telehealth at the core of its COVID-19 Response Plan.
- While most changes are temporary, the positive effect they have the expansion of related infrastructure could accelerate the adoption of digital health solutions down the line.
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